book

Quality Planning and Assurance

Name: Quality Planning and Assurance
Author: Herman Tang
ISBN: 9781119819271

by Herman Tang

November 2021

Intermediate to advanced

352 pages

9h 51m

English

Wiley

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Cover
Title page
Copyright
Forewords
Foreword
Preface
Acknowledgments
About the Author
1 Introduction to Quality Planning
1.1 Quality Definitions1.1.1 Meaning of Quality1.1.2 End-customer Centricity1.1.3 Dimensions of Product and Service Quality1.1.4 Discussion of Service Quality1.2 Quality System1.2.1 Quality Management System1.2.2 Discussion of QMS1.2.3 Quality Target Setting1.2.4 Cost of Quality1.3 Quality Planning1.3.1 Planning Process Overview1.3.2 Considerations in Quality Planning1.3.3 Quality-planning Guideline (APQP)1.3.4 Service Quality PlanningSummaryExercisesReferences
2 Strategy Development for Quality
2.1 Strategic Management2.1.1 Overview of Strategic Management2.1.2 Hoshin Planning Management2.1.3 Implementation Considerations2.2 Risk Management and Analysis2.2.1 Risk Management Overview2.2.2 Risks and Treatments2.2.3 Risk Evaluation2.2.4 Event Tree, Fault Tree, and Bowtie Analysis2.3 Pull and Push Strategies2.3.1 Pull or Push2.3.2 Innovation–push2.3.3 Challenges to Pull and PushSummaryExercisesReferences

3 Customer–centric Planning
3.1 Goal: Design for Customer3.1.1 Customer–driven Development3.1.2 Product/Process Characteristics3.2 Quality Category to Customer3.2.1 Must–be Quality and Attractive Quality3.2.2 Kano Model3.3 Quality Function Deployment3.3.1 Principle of QFD3.3.2 QFD Applications3.3.3 More Discussion of QFD3.4 Affective Engineering3.4.1 Introduction to Affective Engineering3.4.2 Discussion of AE3.4.3 Applications of AESummaryExercisesReferences
4 Quality Assurance by Design
4.1 Design Review Process4.1.1 Introduction to Design Review4.1.2 Design Review Based on Failure Mode4.1.3 Design Review Applications4.2 Design Verification and Validation4.2.1 Prototype Processes4.2.2 Processes of Verification and Validation4.2.3 Discussion of Verification and Validation4.3 Concurrent Engineering4.3.1 Principle of Concurrent Engineering4.3.2 Considerations to CE4.4 Variation Considerations4.4.1 Recognition of Variation4.4.2 Target Setting with Variation4.4.3 Propagation of Variation4.4.4 Quality and VariationSummaryExercisesReferences
5 Proactive Approaches: Failure Modes and Effects Analysis and Control Plan
5.1 Understanding Failure Modes and Effects Analysis5.1.1 Principle of Failure Modes and Effects Analysis5.1.2 FMEA Development5.1.3 Parameters in FMEA5.2 Pre- and Post-work of FMEA5.2.1 Pre-FMEA Analysis5.2.2 FMEA Follow–up5.3 Implementation of FMEA5.3.1 Considerations in FMEA5.3.2 Applications of FMEA5.4 Control Plan5.4.1 Basics of Control Plan5.4.2 Considerations in Control Plan5.4.3 Applications of Control PlanSummaryExercisesReferences
6 Supplier Quality Management and Production Part Approval Process
6.1 Introduction to Supplier Quality6.1.1 Supplier Quality Overview6.1.2 Supplier Selection and Evaluation6.2 PPAP Standardized Guideline6.2.1 Concept of PPAP6.2.2 PPAP Elements6.2.3 PPAP Packages6.3 PPAP Elements in a Package6.3.1 Essential Element (Level 1)6.3.2 Level 2 Elements6.3.3 Level 3 Elements6.3.4 Unique Requirements (Levels 4 and 5)6.4 Supplier Quality Assurance6.4.1 PPAP Preparation and Approval6.4.2 Customer and Supplier Teamwork6.4.3 Supplier Quality to ServiceSummaryExercisesReferences
7 Special Analyses and Processes
7.1 Measurement System Analysis7.1.1 Measurement System7.1.2 Analysis in MSA7.2 Process Capability Study7.2.1 Principle of Process Capability7.2.2 Process Capability Assessment7.2.3 Production Tryout7.3 Change Management in Development7.3.1 Process of Change Management7.3.2 Considerations in Change Management7.3.3 Advancement of Change Management7.4 Quality System Auditing7.4.1 Roles and Processes of Quality Auditing7.4.2 Types of Quality Audit and Preparation7.4.3 Considerations in Quality AuditingSummaryExercisesReferences
8 Quality Management Tools
8.1 Problem-solving Process8.1.1 Plan–Do–Check–Act Approach8.1.2 8D Approach8.1.3 Approaches and Tools8.2 Seven Basic Tools8.2.1 Cause–and–effect Diagram8.2.2 Check Sheet8.2.3 Histogram8.2.4 Pareto Chart8.2.5 Scatter Diagram8.2.6 Control Charts8.2.7 Stratification Analysis8.3 Seven Additional Tools8.3.1 Affinity Diagram8.3.2 Relation Diagram8.3.3 Tree Diagram8.3.4 Matrix Chart (Diagram)8.3.5 Network Diagram8.3.6 Prioritization Matrix8.3.7 Process Decision Program ChartSummaryExercisesReferences
Acronyms and Glossary
Epilogue
Index
End User License Agreement

Content preview from Quality Planning and Assurance

5 Proactive Approaches Failure Modes and Effects Analysis and Control Plan

5.1 Understanding Failure Modes and Effects Analysis

5.1.1 Principle of Failure Modes and Effects Analysis

Process of Failure Modes and Effects Analysis

Any product or service can have various quality problems, such as defects, malfunctions, and delays, when customers use a product or take a service. Minimizing and preventing quality problems is a major task of quality planning in development.

Failure modes and effects analysis (FMEA) is a proactive approach to identify potential failures, assess their possible impacts, and recommend countermeasures in advance. The aims of doing FMEA are:

To identify potential failure modes, and evaluate their possible impacts.
To propose preventive actions, and prioritize these to mitigate higher risks of potential failures and reduce their impacts.
To follow up on implementation plans to ensure improved quality of a product or service.

The FMEA approach can apply to a system, such as a product, service, process, or other business function. FMEAs are normally conducted for new and high-risk subsystems and main functions of a large or complex system. A specific FMEA may be dedicated to a subsystem, such as a design FMEA, service FMEA, or process FMEA. For a new product, both a design FMEA and process FMEA are normally required.

Design FMEA is very similar to the DRBFM (design review based on failure mode) process discussed in Chapter 4, in terms of principle, process, ...

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